CMS Statement on Current Status of Blood Tests for Organ Transplant Rejection

Date:

The Centers for Medicare & Medicaid Services (CMS) confirms that neither CMS nor the Medicare Administrative Contractors (MACs) have made changes that affect patients’ ability to have blood tests used to monitor for organ transplantation rejection covered when ordered by their physicians in medically appropriate circumstances. Patients with transplanted hearts, lungs, or kidneys who meet the coverage criteria for these tests, as laid out in the Local Coverage Determination (LCD), can continue to access these tests in place of a more invasive biopsy.

Palmetto, a Medicare Administrative Contractor, developed the Molecular Testing for Solid Organ Allograft Rejection LCD in accordance with applicable statute and CMS rules, which include a comment and notice period. MACs are organizations that have statutory authority to develop local coverage decisions (LCDs) for their individual jurisdictions.

The Molecular Testing for Solid Organ Allograft Rejection LCD became effective on June 6, 2021. Historically, the standard for assessing transplant rejection or injury has been a biopsy in conjunction with serologic criteria. However, given the invasive nature and risks associated with a biopsy, this LCD covers tests that can potentially negate the need for a biopsy by providing clinicians with actionable information that can be used to help optimize immunosuppressive therapy. This means the test can be used instead of a biopsy when clinically appropriate and meeting the reasonable and necessary guidelines laid out by the MACs. This LCD coverage criteria was developed based on the available evidence and a rigorous public comment process.

Under the Molecular Diagnostic Services Program (MolDX), a program developed by the Palmetto MAC, the MAC focuses on determining coverage for molecular diagnostic tests and other molecular pathology services. Several other MACs have implemented Palmetto’s MolDX program as part of their operations. In the MolDX program, the MACs review all evidence that a manufacturer produces to determine whether an item or service meets the standards for Medicare coverage under the reasonable and necessary standard. 

Over time, the MACs became aware of improper billing and overutilization of these tests. In response, the MACs issued revised billing instructions to providers on March 31, 2023. Billing and coding articles provide additional educational content to help providers, suppliers, and other interested parties better understand the intent of the existing LCD criteria language.

In addition, based on interested parties’ feedback, on August 10, 2023, the MACs released a new proposed LCD, seeking comment and evidence from the public pertaining to proposed changes made for clarity. In this proposed LCD, the coverage criteria remain intact. When ordered by a doctor, these tests continue to be covered for patients in place of a more invasive biopsy.

Now that the comment period on this proposed LCD has closed, the MACs will review the comments, including any clinical evidence received, to inform future decisions about coverage criteria for these tests. Under the existing coverage policies, patients with Medicare can continue to access blood tests for organ transplantation rejection when medically appropriate and ordered by their physicians. CMS remains committed to ensuring transplant patients with Medicare can access the coverage, care, and services they need.

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